Spinal fixation construct and methods of use

ABSTRACT

A spinal fixation construct for aligning vertebral bodies includes a bone screw, a spinal rod, a flexible member, and a fixation member. The spinal rod is disposed within a saddle portion of a housing of the bone screw, and includes an elongated body having a first end and a second end. The spinal rod is formed from a first material having a first modulus of elasticity. The flexible member is coupled to the spinal rod, and includes an elongated body having a first end portion and a second end portion. The flexible member is formed from a second material having a second modulus of elasticity that is different from the first modulus of elasticity. The fixation member includes a threaded body portion and a head portion defining a hole therethrough. A portion of the flexible member extends through the hole of the head portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S/ patent applicationSer. No. 16/108,126, filed on Aug. 22, 2018, which is a divisionalapplication of U.S. patent application Ser. No. 15/042,184, now U.S.Pat. No. 10/064.656, filed on Feb. 12, 2016, which claims the benefitof, and priority to, U.S. Provisional Patent Application Ser. No.62/115,259, filed on Feb. 12, 2015, the entire contents of each of whichare incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates generally to spinal fixation devices, andmore particularly, to a spinal fixation construct and methods of use ina spinal procedure.

BACKGROUND

The spinal column is a complex system of bones and connective tissuesthat provide support for the human body and protection for the spinalcord and nerves. The adult spine includes an upper portion and a lowerportion. The upper portion contains twenty-four discrete bones, whichare subdivided into three areas including seven cervical vertebrae,twelve thoracic vertebrae, and five lumbar vertebrae. The lower portionincludes the sacral and coccygeal bones. The cylindrical shaped bones,called vertebral bodies, progressively increase in size from the upperportion downwards to the lower portion.

An intervertebral disc along with two posterior facet joints cushion anddampen the various translational and rotational forces exerted upon thespinal column. The intervertebral disc is a spacer located between twovertebral bodies. The facets provide stability to the posterior portionof adjacent vertebrae. The spinal cord is housed in the canal of thevertebral bodies. It is protected posteriorly by the lamina. The laminais a curved surface with three main protrusions. Two transverseprocesses extend laterally from the lamina, while the spinous processextends caudally and posteriorly. The vertebral bodies and lamina areconnected by a bone bridge called the pedicle.

The spine is a flexible structure capable of a large range of motion.There are various disorders, diseases, and types of injury, whichrestrict the range of motion of the spine or interfere with importantelements of the nervous system. The problems include, but are notlimited to, scoliosis, kyphosis, excessive lordosis, spondylolisthesis,slipped or ruptured discs, degenerative disc disease, vertebral bodyfracture, and tumors. Persons suffering from any of the above conditionstypically experience extreme and/or debilitating pain, and often timesdiminished nerve function. These conditions and their treatments can befurther complicated if the patient is suffering from osteoporosis, orbone tissue thinning and loss of bone density.

Spinal fixation devices are widely employed in surgical processes forcorrecting spinal injuries and diseases. When the disc has degeneratedto the point of requiring removal, there are a variety of interbodyimplants that may be utilized to take the place of the disc. Theseinclude interbody spacers, metal cages, and cadaver and human boneimplants. In order to facilitate stabilizing the spine and keeping theinterbody in position, other implants are commonly employed, such asbone screws and spinal rods. Depending on the pathology and treatment, asurgeon will select the appropriate spinal rod material and size,specifically, the cross-sectional diameter of the spinal rod.

Subsequent to surgical treatment of a patient's spine is the occurrenceof proximal junctional kyphosis (PJK). PJK is a spinal deformitycondition that may occur if the lumbar lordosis and thoracic kyphosisare not properly restored post-surgery. PJK may also be caused by theaccelerated degeneration of the joint capsules and smaller articularprocesses at one or two levels above or below the junctional region. PJKappears at or above the cranial-most thoracic level treated. Even thoughPJK most commonly occurs in the thoracic region of the spine, it canalso occur in various spinal regions and may occur above or below theinstrument levels and may impact the next adjacent level or two that isnot instrumented. This type of failure is called adjacent level failure.Symptoms of PJK and adjacent level failure include pain, neurologicaldeficit, ambulatory difficulty, and poor maintenance of sagittalbalance. For patients that demonstrate these symptoms, often the onlytreatment is an additional surgery. The incidence rate of PJK may beupward of 50% of long construct, instrumented fusion cases. Factorscontributing to this condition are the end vertebrae selection, facetviolation, weakened structural support due to significant soft tissuedisruption, extensive junctional paraspinal musculature dissection, andloss of integrity of the posterior tension band.

One thought to address the incidence of PJK is to decrease thestructural rigidity of the construct at the top of the construct justbelow the proximal junction, thereby providing a transition from therelatively stiff instrumented spine to the more flexible,non-instrumented spine to minimize facet capsule and muscle disruption.

Spinal rods are typically made of cobalt chrome, stainless steel, ortitanium alloy. However, in order to transition to a less stiffconstruct at the top, other less rigid materials may be employed toprovide the desired stiffness.

A continuing need exists for an improved device, an improved system, andan improved method for performing spine surgery that does not createadditional morbidity post-surgical treatment.

SUMMARY

The present disclosure is directed to fixing spinal vertebrae with aspinal fixation construct having varying stiffness properties along itslength. A flexible member of the spinal fixation construct has reducedstiffness properties as compared to other components of the spinalfixation construct (e.g., a fixation member and/or a spinal rod).

In accordance with an aspect of the present disclosure, a spinalfixation construct for aligning vertebral bodies includes a bone screw,a spinal rod, a flexible member, and a fixation member. The bone screwincludes a housing having a saddle portion and a bone screw memberextending from the housing. The spinal rod is disposed within the saddleportion of the housing of the bone screw, and includes an elongated bodyhaving a first end and a second end. The spinal rod is formed from afirst material having a first modulus of elasticity. The flexible memberis coupled to the spinal rod, and includes an elongated body having afirst end portion and a second end portion. The flexible member isformed from a second material having a second modulus of elasticity thatis different from the first modulus of elasticity. The fixation memberincludes a threaded body portion and a head portion defining a holetherethrough. A first portion of the flexible member extends through thehole of the head portion of the fixation member.

The fixation member may be formed from a third material having a thirdmodulus of elasticity that is different from the first modulus ofelasticity. The first modulus of elasticity and/or the third modulus ofelasticity may be higher than the second modulus of elasticity.

The hole of the fixation member may have a lateral dimension that isdifferent from a longitudinal dimension of the hole.

In embodiments, the elongated body of the flexible member may bebraided.

In some embodiments, the bone screw may include a set screw havingexternal threads configured to engage internal threads of the housing,and the first and second end portions of the flexible member may becompressed against the spinal rod within the saddle portion of thehousing and secured therein by the set screw.

The first end of the spinal rod may define an aperture therethrough, anda second portion of the flexible member may extend through the aperture.The second end of the spinal rod may also define an aperturetherethrough.

In accordance with another aspect of the present disclosure, a methodfor aligning vertebral bodies includes implanting a bone screw into avertebral body of a spine, positioning a portion of a spinal rod withina housing of the bone screw, the spinal rod formed from a first materialhaving a first modulus of elasticity and including an elongated bodyhaving first and second ends, and securing a portion of a flexiblemember to the spinal rod, the flexible member formed from a secondmaterial having a second modulus of elasticity that is lower than thefirst modulus of elasticity, and including an elongated body havingfirst and second end portions.

In embodiments, the method may further include passing a portion of theflexible member around a bony element of the spine. Passing the portionof the flexible member around the bony element may include at least oneof looping the flexible member over a lamina, through a spinous process,or over a spinous process.

In some embodiments, securing the portion of the flexible member to thespinal rod includes placing the first and second end portions of theflexible member adjacent to the portion of the spinal rod positionedwithin the housing of the bone screw, and compressing the first andsecond end portions of the flexible member against the spinal rod with aset screw of the bone screw.

In embodiments, positioning the portion of the spinal rod may includethe spinal rod having an aperture extending through at least one of thefirst or second ends, and securing the portion of the flexible member tothe spinal rod may include passing the portion of the flexible memberthrough the aperture of the spinal rod.

The method may further include tying the first and second end portionsof the flexible member such that the flexible member forms a continuousloop.

In embodiments, the method may include implanting a fixation member intoa bony element of the spine in spaced relation relative to the spinalrod, and securing a portion of the flexible member to the fixationmember. The fixation member may include a head portion defining a holetherethrough, and securing the portion of the flexible member to thefixation member may include passing the portion of the flexible memberthrough the hole of the fixation member.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given above,and the detailed description of the embodiments given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1 is an in situ view of a spinal fixation construct in accordancewith an embodiment of the present disclosure;

FIG. 2 is a perspective view of a fixation member of the spinal fixationconstruct of FIG. 1 ;

FIG. 3A is a perspective view of a flexible member of the spinalfixation construct of FIG. 1 ;

FIG. 3B is a cross-sectional view of the flexible member of FIG. 3A,taken along lines 3B-3B of FIG. 3A;

FIGS. 4A and 4B are cross-sectional views of flexible members inaccordance with other embodiments of the present disclosure;

FIGS. 4C and 4D are side views of flexible members in accordance withyet other embodiments of the present disclosure;

FIGS. 5A-5D are cross-sectional views of flexible members in accordancewith embodiments of the present disclosure;

FIG. 6 is a perspective view of a spinal rod and a bone screw of thespinal fixation construct of FIG. 1 ;

FIG. 7 is an in situ view of a spinal fixation construct in accordancewith another embodiment of the present disclosure;

FIG. 8 is a perspective view of a fixation member of the spinal fixationconstruct of FIG. 7 ;

FIG. 9 is an in situ view of a spinal fixation construct in accordancewith yet another embodiment of the present disclosure;

FIG. 10A is a perspective view of a spinal rod of the spinal fixationconstruct of FIG. 9 ;

FIG. 10B is a perspective view of a spinal rod in accordance withanother embodiment of the present disclosure;

FIG. 11 is an in situ view of a spinal fixation construct in accordancewith yet another embodiment of the present disclosure;

FIG. 12 is an in situ view of a spinal fixation construct in accordancewith another embodiment of the present disclosure; and

FIG. 13 is a perspective view of a spinal implant for use with a spinalfixation construct of the present disclosure.

DETAILED DESCRIPTION

Embodiments of the present disclosure are now described in detail withreference to the drawings in which like reference numerals designateidentical or corresponding elements in each of the several views. Theterm “clinician” refers to a doctor (e.g., a surgeon), a nurse, or anyother care provider, and may include support personnel. Throughout thisdescription, the term “proximal” refers to a portion of a device orcomponent thereof that is closer to a clinician, and the term “distal”refers to the portion of the device or component thereof that is fartherfrom the clinician. “Cranial” refers to a spine segment closer to thehead of a patient, whereas “caudal” refers to the spine segment closerto the feet of the patient. The term “posterior” indicates a directiontoward the patient's back, and the term “anterior” indicates a directiontoward the patient's front. Additionally, in the drawings and in thedescription that follows, terms such as front, rear, upper, lower, top,bottom, and similar directional terms are used simply for convenience ofdescription and are not intended to limit the disclosure. In thefollowing description, well-known functions or constructions are notdescribed in detail to avoid obscuring the present disclosure inunnecessary detail.

Referring initially to FIG. 1 , a spinal fixation construct 1 inaccordance with an embodiment of the present disclosure includes afixation member 10, a flexible member 20, a spinal rod 30, and at leastone bone screw 40. While two spinal fixation constructs 1 are shown inFIG. 1 , the spinal fixation constructs 1 are discussed singularly asthey are substantially identical.

As shown in FIG. 2 , the fixation member 10 includes a proximal end 12including a head portion 14, and a threaded body portion 16 extendingdistally from the head portion 14 to a distal tip 18 along alongitudinal axis “X”. The head portion 14 of the fixation member 10defines a hole 14 a therethrough that is configured and dimensioned toreceive and retain a portion of the flexible member 20 (see e.g., FIG. 1). The hole 14 a has a lateral dimension that is larger than alongitudinal dimension of the hole 14 a. The threaded body portion 16 ofthe fixation member 10 includes a first threaded region 16 a and asecond threaded region 16 b. The fixation member 10 is formed ormachined from a biocompatible metallic material including, but notlimited to, titanium alloy, stainless steel, and cobalt chrome.

As shown in FIG. 3A, the flexible member 20 includes an elongated body22 having a first end portion 22 a and a second end portion 22 b. Theflexible member 20 is formed from a biocompatible material having alower modulus of elasticity than the biocompatible material of thefixation member 10 (see e.g., FIG. 2 ) and thus, the flexible member 20is formed of a less stiff material than that of the fixation member 10.The flexible member 20 may be fabricated from one or more polymericmaterials such as, but not limited to, polyethylene, ultra-highmolecular weight polyethylene, polypropylene, polyetherimide,polysulfone, polyacetal, nylon, polytetrafluoroethylene, andcombinations thereof, and may be formed by injection molding, extruding,compression molding, overmolding, machining or other known methods forshaping polymeric materials as within the purview of those skilled inthe art.

The elongated body 22 of the flexible member 20 has a uniform dimensionalong the length thereof, and as shown in FIG. 3B, is a solid monolithicstructure having a generally rectangular cross-sectional shape. It isenvisioned that the dimensions of the elongated body 22 of the flexiblemember 20 may vary along the length thereof.

Other configurations of the flexible member 20 are also contemplated.For example, in some embodiments, as shown in FIG. 4A, the elongatedbody 22 a of a flexible member 20 a may have an opening 23 definedtherethrough to increase the flexibility of the flexible member 20 a. Insome embodiments, the flexible member may be a composite. As shown, forexample, in FIG. 4B, an elongated body 22 b of a flexible member 20 bhas a core 25 a and sheath 25 b configuration in which the core 25 a andsheath 25 b may be formed of the same or different materials having thesame or different moduli of elasticities. As shown in FIG. 4C, anelongated body 22 c of a flexible member 20 c has a braidedconfiguration in which first strand(s) 27 a of the elongated body 22 care formed from the same or different material having the same ordifferent modulus of elasticity than second strand(s) 27 b of theelongated body 22 c. As another example, as shown in FIG. 4D, anelongated body 22 d of a flexible member 20 d has a layeredconfiguration including two or more layers 29 a, 29 b which may beformed from the same or different materials having the same or differentmodulus of elasticities. Additionally or alternatively, in non-limitingexamples, the flexible member may have other cross-sectional shapes,such as a flexible member 20 e having a circular shape (FIG. 5A), aflexible member 20 f having an elliptical shape (FIG. 5B), a flexiblemember 20 g having a triangular shape (FIG. 5C), a flexible member 20 hhaving a semi-circular shape (FIG. 5D), etc.

It should be understood that the combination of, for example, size,configuration, shape, and/or material selection of the elongated body ofthe flexible member provides the flexible member with a desiredstiffness profile along the length thereof for a desired surgicalapplication.

As shown in FIG. 6 , the spinal rod 30 includes an elongated body 32having opposed ends, and the bone screw 40 includes a housing 42, a bonescrew member 44, and a set screw 46. Housing 42 of bone screw 40includes a saddle portion 42 a within which the spinal rod 30 may beseated. Housing 42 also includes internal threads 42 b configured toengage complementary external threads 46 a of the set screw 46 to securethe set screw 46 within the housing 42 and to secure the spinal rod 30within the saddle portion 42 a of the housing 42. Suitable spinal rodsand bone screws for use in the spinal fixation construct of the presentdisclosure are shown and described in U.S. Patent ApplicationPublication Nos. 2013/0013003 and 2013/0144342, and U.S. Pat. No.8,882,817, the disclosures of which are herein incorporated by referencein their entireties. The spinal rod 30 and bone screw(s) 40 are formedfrom biocompatible metallic materials, such as those listed above withregard to the fixation member 10 and thus, the flexible member 20 isformed of a less stiff material than that of the spinal rod 30 and thebone screw(s) 40.

Referring again to FIG. 1 , in an embodiment of use, the fixation member10 is implanted within a bony element of a spine “S,” such as thepedicle or facet. The bone screws 40 are implanted into vertebral bodies“V” of the spine “S” in spaced relation relative to the fixation member10 and relative to each other, and the spinal rod 30 is positionedwithin the bone screws 40. The flexible member 20 is passed through thehole 14 a (see e.g., FIG. 2 ) of the head portion 14 of the fixationmember 10 such that a portion of the flexible member 20 is securedwithin the head portion 14 of the fixation member 10, and the first andsecond end portions 22 a and 22 b (see e.g., FIG. 3A) of the flexiblemember 20 are placed adjacent to the spinal rod 30 within the saddleportion 42 a (see e.g., FIG. 6 ) of the housing 42 of the bone screw 40,and secured therein by the set screw 46 which compresses the flexiblemember 20 against the spinal rod 30.

Referring now to FIG. 7 , a spinal fixation construct 2 in accordancewith another embodiment of the present disclosure includes a fixationmember 110, a flexible member 20, a spinal rod 30, and at least one bonescrew 40. As shown in FIG. 8 , the fixation member 110 includes aproximal end 112 including a head portion 114 and a threaded bodyportion 116 extending distally from the head portion 114 to a distal tip118 along a longitudinal axis “X”. The head portion 114 of the fixationmember 110 defines a hole 114 a therethrough that is configured anddimensioned to receive a portion of the flexible member 20 (see e.g.,FIG. 7 ). The hole 114 a has a lateral dimension that is smaller than alongitudinal dimension of the hole 114 a. The threaded body portion 116of the fixation member 110 includes a first threaded region 116 a and asecond threaded region 116 b.

In an embodiment of use, as shown in FIG. 7 , the fixation member 110 isimplanted within a bony structure of a spine “S,” such as the pedicle orfacet. The bone screws 40 are implanted into vertebral bodies “V” of thespine “S” in spaced relation relative to the fixation member 110 andrelative to each other, and the spinal rod 30 is positioned within thebone screws 40. The flexible member 20 is passed through the hole 114 a(see e.g., FIG. 8 ) of the head portion 114 of the fixation member 110such that a portion of the flexible member 20 is secured within the headportion 114 of the fixation member 110, and the first and second endportions 22 a and 22 b (see e.g., FIG. 3A) of the flexible member 20 areplaced adjacent to the spinal rod 30 within the saddle portion 42 a (seee.g., FIG. 6 ) of the housing 42 of the bone screw 40, and securedtherein by the set screw 46.

Referring now to FIG. 9 , a spinal fixation construct 3 in accordancewith another embodiment of the present disclosure includes a fixationmember 110, flexible member 20, a spinal rod 300, and at least one bonescrew 40. As shown in FIG. 10A, the spinal rod 300 includes an elongatedbody 302 having a first end 304 and a second end 306. The first end 304defines an aperture or through hole 304 a therethrough which isconfigured and dimensioned to engage a portion of the flexible member 20(see e.g., FIG. 9 ). In some embodiments, shown in FIG. 10B, a spinalrod 300′ includes an elongated body 302′ having a first end 304 definingan aperture 304 a therethrough, and a second end 306′ defining anaperture 306 a therethrough for use with a flexible member.

In an embodiment of use, shown in FIG. 9 , the fixation member 110 isimplanted within a bony element of a spine “S,” the bone screw 40 isimplanted into a vertebral body “V” of the spine “S” in spaced relationrelative to the fixation member 110, and the spinal rod 300 ispositioned within the bone screw 40. The flexible member 20 is passedthrough the hole 114 a (see e.g., FIG. 8 ) of the fixation member 110and the aperture 304 a of the spinal rod 300 such that portions of theflexible member 20 are secured within the head portion 114 of thefixation member 110 and the first end 304 of the spinal rod 300. Thefirst and second end portions 22 a and 22 b (see e.g., FIG. 3A) of theflexible member 20 are secured, e.g., by being tied or clamped, to thefixation member 110, the spinal rod 300, and/or to each other, such thatthe flexible member 20 forms a continuous loop.

Referring now to FIG. 11 , a spinal fixation construct 4 in accordancewith another embodiment of the present disclosure includes a flexiblemember 20, two spinal rods 300, and a plurality of bone screws 40. In anembodiment of use, the bone screws 40 are implanted into vertebralbodies “V” of the spine “S,” on opposed sides of the spinous process“SP,” and the spinal rods 300 are positioned within the bone screws 40.The flexible member 20 is passed through the apertures 304 a of thespinal rods 300 such that portions of the flexible member 20 areretained therein, and the flexible member 20 is looped around a lamina“L” of the spine “S.” The first and second end portions 22 a, 22 b (FIG.3A) of the flexible member 20 are secured, e.g., by being tied orclamped, to the spinal rod(s) 300 and/or to each other.

As shown in FIG. 12 , a spinal fixation construct 5 in accordance withanother embodiment of the present disclosure includes two fixationmembers 110, a flexible member 20, two spinal rods 300, and a pluralityof bone screws 40. In an embodiment of use, the fixation members 110 areimplanted within a bony element of a spine “S” on opposed sides of thespinous process “SP.” The bone screws 40 are implanted into vertebralbodies “V” of the spine “S” in spaced relation relative to the fixationmembers 110, also on opposed sides of the spinous process “SP,” and thespinal rods 300 are positioned within the bone screws 40. The flexiblemember 20 is passed through the holes 114 a (see e.g., FIG. 8 ) of thefixation member 110 and the apertures 304 a of the spinal rods 300, suchthat the flexible member 20 is looped around the spinous process “SP.”The first and second end portions 22 a, 22 b (FIG. 3A) of the flexiblemember 20 are secured, e.g., by being tied or clamped, to the fixationmember 110, the spinal rod 300, and/or to each other.

While the embodiments of the spinal fixation constructs 1-5 have beenshown with the flexible member 20 oriented in a cranial orientation tofacilitate reducing the stress impact on the cranial, non-instrumentedadjacent level to the spinal fixation construct 1-5, it should beunderstood that if a less stiff portion is desired at the caudal end ofthe spinal fixation construct 1-5, the spinal fixation construct 1-5 maybe turned 180 degrees to allow the flexible member 20 to be located in acaudal orientation and/or the spinal fixation construct 1-5 may bestopped one level above the desired level. Should both the cranial andcaudal ends require less stiffness, both ends may include the flexiblemember 20. Further, as discussed above, the modulus of elasticity of theflexible member 20 is different from the modulus of elasticity of theother components of the spinal fixation construct 1-5 (e.g., the spinalrod 30, 300, 300′), and thus, a range of motion is maintained betweenadjacent vertebrae without spinal fusion.

Other embodiments are also envisioned. For example, the flexible membermay be configured to loop around a portion of a bony element, such as avertebral body, and coupled to a spinal rod with a spinal implant, suchas an implant depicted in U.S. Patent Application No. 2014/0257397, thedisclosure of which is herein incorporated by reference in its entirety.As shown in FIG. 13 , the spinal implant 500 includes an implant housing502 that defines a rod passage 502 a and an implant passage 502 b. Therod passage 502 a is configured to receive a portion of a spinal rod 30and the implant passage 502 b is configured to receive a portion of theflexible member 20. An implant set screw 504 engages the flexible member20 when the flexible member 20 is received within the implant passage502 b to fix the flexible member 20 relative to the implant housing 502,and a rod set screw 506 engages the spinal rod 30 disposed within therod passage 502 a to fix the spinal rod 30 relative to the implanthousing 502. Further, a surgical instrument, such as that described incommonly owned U.S. patent application Ser. No. 14/644,428, thedisclosure of which is herein incorporated by reference in its entirety,may be used by a clinician to tension the flexible member 20 about thebony element and/or fix the flexible member 20 to the spinal implant500.

The spinal fixation construct may be provided in a kit. The kit is anassembled package with at least one flexible member, at least onefixation member, at least one spinal rod, and/or bone screw(s). The kitmay include any and/or all of the configurations of: the flexible member20, 20 a-20 h; the fixation members 10, 110; the spinal rods 30, 300,300′; and/or the bone screws 40, described above. The kit may include aplurality of flexible members, fixation members, spinal rods, and/orbone screws having, for example, different configurations, diameters,lengths, and/or shapes. Accordingly, a clinician may pick and choosecomponents to form a spinal fixation construct with a desired stiffnessprofile for a surgical procedure.

In embodiments, a clinician may perform any required anterior proceduresand then turn the patient to a prone position. In the prone position,the clinician can create a spinal fixation construct which may be acombination of any of the components described above, and includeadditional components, such as bone anchors, transverse connectors, etc.The clinician implants any fixation members, bone screws, and/or boneanchors, and spinal rods posteriorly, and then supplements the posteriorinstrumentation with the flexible member. The flexible member may belooped over the lamina, through the spinous process, over the spinousprocess, or anchored to a fixation member and/or a spinal rod, asdesired by the clinician for the particular surgical procedure. Thefirst and second end portions of the flexible member may be placed inthe saddle portion of a bone screw adjacent the spinal rod and locked inplace by the set screw of the bone screw, one or both end portions maybe tied through a through hole of a fixation member and/or a spinal rod,as desired by the clinician for the particular surgical procedure. Theflexible member may be placed at the cranial and/or caudal end of thespinal fixation construct.

Persons skilled in the art will understand that the structures andmethods specifically described herein and shown in the accompanyingfigures are non-limiting exemplary embodiments, and that thedescription, disclosure, and figures should be construed merely asexemplary of particular embodiments. It is to be understood, therefore,that the present disclosure is not limited to the precise embodimentsdescribed, and that various other changes and modifications may beeffected by one skilled in the art without departing from the scope orspirit of the disclosure. Additionally, the elements and features shownand described in connection with certain embodiments may be combinedwith the elements and features of certain other embodiments withoutdeparting from the scope of the present disclosure, and that suchmodifications and variation are also included within the scope of thepresent disclosure. Accordingly, the subject matter of the presentdisclosure is not limited by what has been particularly shown anddescribed.

What is claimed is:
 1. A spinal fixation construct comprising: a spinalimplant defining a rod passage; a first spinal rod including a body andan aperture defined along the body, formed directly through the body,and enclosed by the body, a portion of the spinal rod positioned withinthe rod passage; a first monolithic fixation member including a threadedshaft and a head portion defining a passageway; and a first flexiblemember defining a loop, a portion of the loop extending entirely throughthe aperture of the spinal rod, wherein the first flexible memberextends from the aperture of the spinal rod and through the passagewayof the head portion of the first fixation member.
 2. The spinal fixationconstruct of claim 1, wherein the aperture of the first spinal rod isdefined at a first end of the spinal rod.
 3. The spinal fixationconstruct of claim 1, wherein the first spinal rod includes a secondaperture defined along the body.
 4. The spinal fixation construct ofclaim 3, wherein the aperture of the first spinal rod is defined at afirst end of the first spinal rod and the second aperture of the firstspinal rod is defined at a second end of the first spinal rod.
 5. Thespinal fixation construct of claim 1, further comprising a firstfixation member including a head portion defining a passageway.
 6. Thespinal fixation construct of claim 5, wherein the first flexible memberextends from the aperture of the spinal rod and through the passagewayof the head portion of the first fixation member.
 7. The spinal fixationconstruct of claim 6, further comprising: a second fixation memberincluding a head portion defining a passageway therethrough; and asecond spinal rod including a body and an aperture defined along thebody of the second spinal rod.
 8. The spinal fixation construct of claim7, further comprising a second flexible member extending through theaperture of the second spinal rod and through the passageway of the headportion of the second fixation member.
 9. The spinal fixation constructof claim 8, wherein the first rod and the first flexible member extendsparallel to the second rod and the second flexible member.
 10. Thespinal fixation construct of claim 7, wherein the first flexible memberextends through the aperture of the second spinal rod and through thehole of the head portion of the second fixation member.
 11. The spinalfixation construct of claim 10, wherein the first flexible member isconfigured to be looped about a bony element.
 12. The spinal fixationconstruct of claim 5, wherein the first flexible member is wrapped abouta portion of the head portion of the first fixation member.
 13. Thespinal fixation construct of claim 12, wherein the first flexible memberis wrapped about an axis parallel to a central axis defined by thefixation member.
 14. A spinal fixation construct comprising: a spinalimplant defining a rod passage; a first spinal rod including a bodyextending between a first end and a second end along a longitudinal axisand an aperture formed directly through the body and enclosed by thebody, a portion of the spinal rod positioned within the rod passage; afirst monolithic fixation member including a threaded shaft and a headportion defining a passageway; and a first flexible member defining aloop connected to the aperture of the first spinal rod, such that aportion of the flexible member defining the loop is substantiallyparallel to the longitudinal axis of the rod and extends beyond thefirst end of the spinal rod, wherein the first flexible member extendsfrom the aperture of the spinal rod and through the passageway of thehead portion of the first fixation member.
 15. The spinal fixationconstruct of claim 14, wherein the first spinal rod includes theaperture defined along the body at the first end of the spinal rod. 16.The spinal fixation construct of claim 15, wherein the first spinal rodincludes a second aperture defined along the body at the second end ofthe spinal rod.
 17. The spinal fixation construct of claim 14, furthercomprising a first fixation member including a head portion defining apassageway.
 18. The spinal fixation construct of claim 17, wherein thefirst flexible member extends through the passageway of the head portionof the first fixation member.
 19. The spinal fixation construct of claim17, wherein the first flexible member extends from the aperture of thespinal rod and through the passageway of the head portion of the firstfixation member.
 20. The spinal fixation construct of claim 17, whereinthe first flexible member is wrapped about a portion of the headportion.